Method and system for evaluation of functional cardiac electrophysiology

ABSTRACT

An organ evaluation device, system, or method is configured to receive electrophysiological data from a patient or model organism and integrates the data in a computational backend environment with anatomical data input from an external source, spanning a plurality of file formats, where the input parameters are combined to visualize and output current density and/or current flow activity having ampere-based units displayed in the spatial context of heart or other organ anatomy.

CROSS-REFERENCE

This application is a continuation of U.S. application Ser. No.15/607,053, filed May 26, 2017, now issued as U.S. Pat. No. 10,076,256on Sep. 18, 2018, which is a continuation of U.S. application Ser. No.15/220,982, filed Jul. 27, 2016, now issued as U.S. Pat. No. 9,788,741on Oct. 17, 2017, which is a continuation of U.S. application Ser. No.14/941,455, filed Nov. 13, 2015, now issued as U.S. Pat. No. 9,433,363on Sep. 6, 2016, which claims the benefit of U.S. ProvisionalApplication No. 62/181,567, filed Jun. 18, 2015, and U.S. ProvisionalApplication No. 62/181,599, filed Jun. 18, 2015, each of which areincorporated herein by reference in its entirety.

SUMMARY

Described herein are devices, systems, media, and methods fornon-invasively evaluating an organ. Described herein are devices,systems, media, and methods for non-invasively evaluating the functionof an organ of an individual. Described herein are devices, systems,media, and methods for non-invasively diagnosing and localizingstructural abnormalities in an organ of an individual. In someembodiments, the organ being monitored is a brain. In some embodiments,the organ being monitored is a heart. In some embodiments, the organbeing monitored is a digestive organ including the liver, gallbladder,pancreas, stomach, small bowel, and large bowel.

Described herein are devices, systems, media, and methods for accuratelynon-invasively diagnosing and localizing cardiac arrhythmia. Accurateevaluation of cardiac arrhythmia with localization of an arrhythmiafacilitates accurate and successful arrhythmia treatment while furtherbenefiting the individual and the physician by enabling reducedradiation exposure during the procedure. The use of creating distributedcurrent vectors in units of amperes based upon magnetic fieldmeasurements of electrical activity allows access to deeper sources ofelectrical activity in the heart through providing a physiological basisfor rhythm or lack thereof, as well as representing spatially theelectrical activity of heart tissue with anatomical context. Thesemeasurements allow access to tangential fields and insight into theendocardium, vital areas of interest for clinicians skilled in this art.These measurements create vector representations of the organ anatomyand provide graphical, three dimensional representations showing theanatomy and electrophysiology including abnormalities thereof,throughout the depth of the organ.

Described herein is a system for evaluating an organ of an individual inneed thereof, comprising: an organ electromagnetic sensor configured tosense a magnetic field associated with said organ, and to couple with acomputing device, wherein said computing device is configured to:receive a magnetic field data associated with said organ from saidelectromagnetic sensor; translate said magnetic field data associatedwith said organ to at least one electrical current vector associatedwith said organ; and combine graphically said at least one electricalcurrent vector with an image of said organ to generate an electricalcurrent density map of said organ for use in evaluating said organ. Insome embodiments, said evaluation of said organ is non-invasive. In someembodiments, said computing device is further configured to display saidelectrical current density map together with said at least oneelectrical current vector. In some embodiments, said organ is a heart.In some embodiments, said computing program is further configured toidentify an arrhythmia. In some embodiments, said computing program isfurther configured to identify an arrhythmogenic focus in said heart. Insome embodiments, said current map comprises one or more colored areaseach corresponding to said current density associated with each of saidcolored areas. In some embodiments, said organ is a brain. In someembodiments, said computing program is further configured to identify anischemic focus in said brain. In some embodiments, said processorreceives said image of said organ from an imaging system. In someembodiments, said imaging system comprises an ultrasound. In someembodiments, said imaging system comprises a fluoroscope. In someembodiments, said image is a three dimensional image. In someembodiments, said three dimensional image is generated from two or moretwo dimensional images. In some embodiments, said program is configuredto cause said processor to further receive demographic data associatedwith said individual. In some embodiments, said demographic datacomprises one or more of age, race, gender, and medical history of saidindividual. In some embodiments, said received demographic dataassociated with said individual is used to identify a three dimensionalimage of an organ of a different individual, wherein the demographicdata associated with said individual and demographic data associatedwith said different individual are essentially identical in one or moreof said age, said race, said gender, and said medical history. In someembodiments, said image comprises said image of said organ of saiddifferent individual. In some embodiments, said program is configured tocause said processor to further receive biometric data associated withsaid individual. In some embodiments, said biometric data comprises oneor more of heart rate, blood pressure, and temperature of saidindividual. In some embodiments, said computing program is furtherconfigured to generate an evaluation of said organ comprising saidelectrical current vector map and said biometric data.

Described herein is a computer implemented method for evaluation throughdetecting, localizing and quantifying arrhythmogenic substrates in theheart, comprising the steps of providing an electromagnetic sensordevice having at least one processor configured to execute instructionsfrom a software application; and providing a computer backend having atleast one processor configured to execute instructions from a softwareapplication having a plurality of inputs and outputs; and providingelectrical activity data as function of electromagnetic activity inmagnetic data values for cardiac tissue as an output of said sensor andinput of said backend, wherein said data includes a representativeseries of recordings defining distributed cardiac electromagneticactivity in three dimensional vector space during a specified timeperiod and specified time period markers for the aforementionedrecordings; and utilizing anatomical data for cardiac tissue, whereinsaid data includes a plurality of data files providing electronic threedimensional mappings of heart geometry embodied on non-volatile memory;and processing by said computer processor the input magnetic activitydata provided by said sensor and input anatomical data, wherein the stepof processing includes calculating a plurality of distributed, spatiallyaccurate electrical current vectors (with units of amperes) in threedimensional space and uniquely identifying and outputting them inreference to anatomical structures found within said heart geometryfiles; and displaying both electrical current vectors and anatomicaldata simultaneously through the process of image registration, whereinsaid registration involves functional overlay of three dimensionalanatomical reconstruction with electroanatomical data provided bycomputational processing. In some embodiments, the method additionallycomprises the steps of: providing a software application by means ofwhich a user interface through which computer processing may occur iscreated; and providing a system for the importation and utilization oftwo dimensional or three dimensional data embodied in a plurality offiletypes relating to anatomical geometry; and providing a system forthe importation and utilization of magnetic field data provided by asaid electromagnetic sensor device. In some embodiments, the methodadditionally comprises the steps of: providing an electronic visualdisplay software application by means of which both magnetic amplitudewaveforms and which distribution vectors can be observed; andinterpreting by said application components of three dimensionalanatomical distributed current models through a spatially oriented userinterface; and said user interface allows for manual manipulationthrough said user interface of spatial observation for the individual;and wherein said manipulation includes alteration of said image throughsaid computational backend and alteration includes manipulation ofnonstructural qualitative factors including but not limited to as color,position, and opacity. In some embodiments, said accumulated electricalvector data involve identification of unique spatial landmarks andstructures; and said embodied, predetermined anatomical image datainvolve unique identification of corresponding structures and landmarks;and said integration of electrical vector and electronically importedanatomical image data allows for joint registration of electrical andanatomical data based on landmark and structure identification, whereinregistration refers to data-skin overlay of a three dimensional imagesuch that quantitative data is displayed qualitatively with a pluralityof color gradients bound to certain quantitative scales in threedimensional space, with particular relation to said structures andlandmarks. In some embodiments, said predetermined embodied anatomicaldata for selection comprises a plurality of indicated demographic andlifestyle factors, and wherein the demographics may involve but are notlimited to factors of health status, age, gender, a priori illness,diet, smoking, and substance use. In some embodiments, the process ofselection of said data involves external selection as a function of saidfactors. In some embodiments, the step of interpreting integratedvector-spatial data involves computational output through an individual.In some embodiments, the method additionally comprises the step ofconfiguring electrical activity data provided by said processor, whereinthe step of configuring includes determining the file format of the dataprovided. In some embodiments, the step of processing includescalculating distributed cardiac current vector activity in dynamic, realtime parameters. In some embodiments, the method additionally comprisesthe steps of providing an activity database of said current densityoutput having baseline activity recordings; and interpreting by saidprocessor input magnetic data and externally selected anatomical data,wherein the step of interpreting includes comparing provided data withdatabase baseline activity recordings; and evaluating by said processorthe comparison of activity as a function of risk assessment, wheregreater deviations from accepted baseline activity are indicated ashigher risk factors and are directly related. In some embodiments, saidsensor is a Magnetocardiogram system with a network comprised of aplurality of said electromagnetic sensors.

Described herein is a computational method for detecting, localizing andquantifying arrhythmogenic substrates in the heart, comprising the stepsof: providing an electromagnetic sensor device having at least oneprocessor configured to execute instructions from a softwareapplication; and providing a computer backend having at least oneprocessor configured to execute instructions from a software applicationhaving a plurality of inputs and outputs; and providing electricalactivity data as function of electromagnetic activity in magnetic datavalues for cardiac tissue as an output of said sensor and input of saidbackend, wherein said data includes a representative series ofrecordings defining distributed cardiac electromagnetic activity inthree dimensional vector space during a specified time period andspecified time period markers for the aforementioned recordings; andutilizing anatomical data for cardiac tissue, wherein said data includesthree dimensional mapping of heart geometry acquired by means of eitherreconstruction from a series of two dimensional images, or importing ofa three dimensional file; and processing by said computer processor theinput magnetic activity data provided by said sensor and inputanatomical data, wherein the step of processing includes calculating aplurality of distributed, spatially accurate electrical current vectors(with units of amperes) in three dimensional space and uniquelyidentifying and outputting them in reference to anatomical structures;and displaying both electrical current vectors and anatomical datasimultaneously through the process of image registration, wherein saidregistration involves functional overlay of three dimensional anatomicalreconstruction with electroanatomical data provided by computationalprocessing. In some embodiments, the method additionally comprises thesteps of: providing a software application by means of which a userinterface through which computer processing may occur is created; andproviding a system for the importation and utilization of two or threedimensional data embodied in a plurality of filetypes relating toanatomical geometry; and providing a system for the importation andutilization of magnetic field data provided by a said electromagneticsensor device. In some embodiments, the method additionally comprisesthe steps of: providing an electronic visual display by said softwareapplication by means of which both magnetic amplitude waveforms andwhich distribution vectors can be observed; and interpreting by saidapplication components of three dimensional anatomical distributedcurrent models through a spatially oriented user; and said userinterface allows for manual manipulation through said user interface ofspatial observation for the individual; and wherein said manipulationincludes alteration of said image through said computational backend andalteration includes manipulation of nonstructural qualitative factorsincluding but not limited to as color, position, and opacity. In someembodiments, said accumulated electrical vector data involveidentification of unique spatial landmarks and structures; and saidanatomical image data involve unique identification of correspondingstructures and landmarks; and the integration of electrical vector andelectronically imported anatomical image data allows for jointregistration of electrical and anatomical data based on landmark andstructure identification, wherein registration refers to data-skinoverlay of a three dimensional image such that quantitative data isdisplayed qualitatively with a plurality of color gradients bound tocertain quantitative scales in three dimensional space, with particularrelation to said structures and landmarks. In some embodiments, the stepof interpreting integrated vector-spatial data involves computationalprocesses through an individual; and wherein said computationalprocesses involve utilization of Maxwell's equations to solve fordistributed cardiac current vectors for an individual. In someembodiments, the method additionally comprises the step of configuringelectrical activity data provided by said processor, wherein the step ofconfiguring includes determining the file format of the data provided.In some embodiments, the step of processing includes calculatingdistributed cardiac current vector activity in terms of ampere-baseddynamic, real time parameters wherein the step of processing saidcardiac current vectors involves the solution of an inverse problemusing Maxwell's electromagnetic equations to determine the relationshipbetween Magnetic Field and Current Density for an individual. In someembodiments, said sensor is a Magnetocardiogram system with a networkcomprised of a plurality of said electromagnetic sensors.

Described herein is a system for detecting, localizing and quantifyingarrhythmogenic substrates in the heart for an individual, comprising: anelectromagnetic sensor network and computer backend having at least oneprocessor and memory, wherein said processor is configured to executeinstructions from a software application to cause the electronic deviceto perform the following step; processing electrical activity data forcardiac tissue, wherein said data includes a representative series ofrecordings defining distributed cardiac electrical activity in threedimensional vector space during a specified time period and specifiedtime period markers for the aforementioned recordings; and wherein thestep of processing includes calculating a plurality of distributed,spatially accurate vectors with units of electrical current in threedimensional space and uniquely identifying them in reference toanatomical structures. In some embodiments, said accumulated electricalvector data involves identification of unique spatial landmarks andstructures; and said anatomical image data involve unique identificationof corresponding structures and landmarks; and said integration ofelectrical vector and anatomical image data allows for jointregistration of electrical and anatomical data based on landmark andstructure identification In some embodiments, the step of interpretingintegrated vector-spatial data involves computational output through anindividual. In some embodiments, the step of processing includescalculating distributed cardiac current vector activity as a functionwith outputs in units of amperes in dynamic real time.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee:

FIG. 1 exemplifies a schematic representation of the steps of anembodiment of the organ evaluation method;

FIG. 2 exemplifies an exemplary embodiment of system for evaluating anorgan of an individual;

FIG. 3 exemplifies an embodiment of a cardiac evaluation system displayshowing a current density and current vector map of a heart of anindividual comprising of combined functional current data as observedand manipulated in the software application;

FIG. 4 exemplifies a screenshot of an embodiment of a cardiac evaluationsystem display showing a current density map of a heart of an individualincluding an extraction tool;

FIG. 5 exemplifies a screenshot of an embodiment of a cardiac evaluationsystem display showing a cardiac current map comprising an endocardialanalysis;

FIG. 6 exemplifies a screenshot of an embodiment of a cardiac evaluationsystem display showing a wireframe perspective of a cardiac currentdensity map. A wireframe perspective comprises a higher resolutionperspective wherein a current density is sensed and displayed over asmaller region of surface of the heart;

FIG. 7 exemplifies screenshot of an embodiment of a cardiac evaluationsystem display showing a cardiac current density map of an isolated leftventricle;

FIG. 8 exemplifies a screenshot of an embodiment of a cardiac evaluationsystem display showing a cardiac current density map of an isolatedright ventricle;

FIG. 9 exemplifies a screenshot of an embodiment of a cardiac evaluationsystem display showing a cardiac current density map of a heart during aQRS complex of an ECG. As shown, a cardiac current density map may becombined with ECG data to generate an evaluation of a heart of anindividual, wherein a cardiac current density map is generated while theindividual has an ECG measured;

FIG. 10 exemplifies as screenshot of an embodiment of a cardiacevaluation system display showing an embodiment of a dynamic currentdensity of an individual in atrial fibrillation;

FIG. 11 exemplifies a computer system that is programmed or otherwiseconfigured to noninvasively evaluate an organ.

DETAILED DESCRIPTION

Various organs of the mammalian body including, for example, the heart,brain, and digestive organs, may malfunction leading to disease.Accurate diagnoses of organ malfunction are critical in terms of beingable to provide accurate therapy and avoid unintended complications.

For example, the heart coordinates contraction through an electricalcurrent that travels through the myocardium of different regions of theheart in a predictable pattern in the healthy individual. If the travelof the electrical current through the heart is abnormal, an individualwill typically suffer an aberrant cardiac contraction which may bediagnosed as an arrhythmia. Millions of patients suffer from cardiacarrhythmias, many of which are life threatening.

Arrhythmia is typically diagnosed based on both patient history andcardiac evaluation technology. Traditional cardiac evaluating modalitiesused to diagnose arrhythmia may include the electrocardiogram andCardiac MRI.

Patients with certain arrhythmias diagnosed with the typical diagnosticapproaches, which are based on patient history and the traditionalevaluating modalities, are treated with cardiac catheter ablation.Studies show that the accuracy of cardiac catheter ablation based on thetypical diagnostic approaches is only around 50-80%.

I. Organ Evaluation Devices and Their Use

Disclosed herein are devices, systems, media, and methods configured toevaluate an organ of an individual in terms of, for example, thephysiology of the organ or, for example, the anatomical structure of anorgan. In some embodiments, an abnormality in an organ is identifiedusing the devices, systems, media, and methods described herein. In someembodiments, an identified abnormality may be localized to a particulararea of an organ.

The devices, systems, media or methods disclosed herein may beconfigured to evaluate the function of the brain of an individual whosuffered an ischemic event. An ischemic event affecting the brain may,for example, cause a decrease or absence of an electrical current. Usingthe devices, systems, media, and methods described herein an area ofdecreased or absent electrical current in the brain is localized.

The devices, systems, media or methods disclosed herein may also beconfigured to evaluate an abnormality in the function of the heart of anindividual with an irregular heartbeat. An irregular heartbeat may, forexample, comprise an abnormal current flow pattern through themyocardium of the heart of the individual suffering from the arrhythmia.When used to evaluate the heart, the devices systems, media, and methodsdescribed herein may be configured to localize an abnormal current flowdensity or pattern in the myocardium of an individual and are thusconfigured to localize an arrhythmogenic focus in these individuals.

FIG. 1 exemplifies a schematic representation of the steps of evaluatingthe organ. In a step 1000 an image of the organ is selected. In someembodiments, an image of the organ of an individual is acquired throughany suitable visualization technique, visualization techniques includebut are not limited to CT scan, MRI, Ultrasound, angiogram, nuclearscan, X-ray, and fluoroscopy. In some embodiments, the image of an organis demographically matched to the organ of the individual whose organ isevaluated. The demographically matched organ is matched to the organ ofthe individual whose organ is being evaluated based on a matching offeatures such as demographic and/or clinical features. Alternatively oradditionally, a three dimensional image of the organ of the individualbeing evaluated is constructed from, for example, one or more twodimensional images of the organ of the individual.

In some embodiments, one or more two dimensional images of an organ areused to generate a three dimensional image of the organ using softwareconfigured to import one or more two dimensional images of the organ anduse them to construct a three dimensional image of the organ based onthe one or more two dimensional images. Two dimensional images areimported from a computer, storage medium, network, or cloud, whereinsaid two dimensional images may be in a variety of file formats. Thesetwo dimensional images may comprise, for example, slices of an organ.These two dimensional images may comprise, for example, different viewsof an organ, as in, for example, AP, oblique, and lateral X-ray images.

Once obtained, these two dimensional images are characterized. In someembodiments, an image is characterized with respect to the imagingmodality (i.e. X-ray, CT, etc.). In some embodiments, an image ischaracterized in terms of the type of image that is acquired (i.e. achest x-ray, abdominal x-ray, abdominal CT). In some embodiments, animage is characterized in terms of its quality. Further, the obtainedimages are transformed into maps of boundary points. In someembodiments, the boundary points represent the borders or outlines of anorgan. In some embodiments, the boundary points represent a border oroutline of a slice or portion of an organ. In some embodiments,successive slices or views of an organ with given parameters of slicethickness and/or orientations in space are oriented in three dimensionalspace and then joined to create a computer rendered mesh of the geometryof the organ for which the two dimensional images were obtained.

Segmentation of organ location in terms of sensed data associated withan organ is further performed. Because the anatomical location notoccupied by an organ does not generate an electromagnetic field,segmentation is achieved by identifying and segmenting locations withand without electromagnetic measurements. Segmentation thus aids in theidentification of an organ within an image that contains the organ aswell as other structures by identifying and segmenting regions fromwhich measurements are sensed and regions from which they are not.

The devices, systems, media, and methods described herein also include aregistration process, wherein the registration process comprises theoverlaying of sensed data associated with an organ (e.g., electricalcurrents) on an organ template geometry. When segmentation has beenapplied in response to sensed data associated with an organ the organgeometry of an individual is identified and one or more geometricfeatures are recognized to register the individual's measurements to anorgan template geometry. In some embodiments, segmentation andregistration are combined into a single process. In some embodiments,segmentation is not performed, and the measurement data is used toregister to a template organ.

Alternatively, a three dimensional image or template of an organ ororgan structure may be generated by pixel intensity gradient analysis.Pixels in a two dimensional image may be mapped in accordance with theirintensity which corresponds to degree of absorbance of an x-ray beam.The organ tissue will typically absorb a transmitted X-ray beam to alarger degree than any surrounding empty space around the organ. Thecontrast between the high intensity pixels at the border of the image ofthe organ with the surrounding empty tissue space (which will compriserelatively low intensity pixels) defines the edges of the organ. Oncethe edges of the organ are mapped out, one or more additional twodimensional images of the same organ are acquired and analyzed in thesame way. Results of the pixel intensity analysis of the two or moreimages are compared and combined to generate voxels and in this waymultiple two dimensional images of the same organs may then be used togenerate three dimensional volumes based on the one or more pixelintensity maps generated.

Alternatively or additionally, a two or three dimensional image of anorgan is constructed based on the sensed data associated with an organfor the organ being evaluated. For example, input magnetic fieldparameters linked to spatial collection points are filtered usingelectronic spatial filters (e.g., recursively updated gram matrix) whichutilizes known cardiac conduction patterns to numerically estimate theboundaries of electrical flow, thereby determining the shape of theorgan, wherein the accuracy is a function of the number of samplingpoints and the parameters of the conduction model being used.

The devices, systems, media, and methods described herein are configuredto combine an anatomically correct representation of an organ,comprising an image or reconstruction of an organ of said individual orwith an image of an organ demographically matched to the individual,with sensed data associated with an organ (e.g. current vector and/orcurrent density data) in order to generate a current density and/orcurrent vector map of the organ. The current density and/or currentvector map of the organ displays one or more current vectors and one ormore current densities associated with one or more anatomical locationsof the organ.

In a step 1002, magnetic signal recording and use comprises sensing dataassociated with an organ using, for example, one or more sensors. Insome embodiments, the sensed data associated with an organ, which issensed by the one or more electromagnetic sensors, comprises a magneticfield associated with an organ. In some embodiments, sensed dataassociated with an organ comprises current or one or more currentvectors.

The devices, systems, media, and methods described herein are configuredto sense a magnetic field associated with an organ and translate thatdata to one or more current vectors of the organ, wherein the one ormore current vectors comprise current density and/or flow through thetissue of the organ being evaluated. The one or more sensors compriseone or more electromagnetic sensors.

In a step 1004, sensed data associated with an organ comprisingdistributed current magnetic field data is converted to current vectordata. Alternatively or additionally, current vector data from the organbeing evaluated is directly sensed.

In a step 1006, registration and visualization occurs. Registration andvisualization comprises overlaying sensed data associated with an organon top of an image of said organ or an image of a demographicallymatched organ. As described, in some embodiments, the sensed dataassociated with an organ comprises magnetic field data, which isconverted to one or more current vectors that correspond to currentdensity and/or current flow through the tissue of an organ. The senseddata associated with an organ is localized to a specific anatomicallocation on the organ and is overlaid on the specific anatomicallocation on the image of the organ associated with said data so thatthere is a direct correspondence between the sensed data associated withan organ and the anatomical location on the organ to which the data waslocalized.

Described herein are devices, systems, media and methods configured togenerate or construct a visualization of anatomical electrical activityfor an organ of an individual. The devices, systems, media, and methodsare further configured to interpret and/or integrate vector-spatial datausing computational output and visualization through a computer softwareapplication which displays and outputs this data in the context of humananatomy through magnetic conversion and subsequent registration withanatomical data.

II. Organ Evaluation Systems

FIG. 2 exemplifies an exemplary embodiment of system 2000 for evaluatingan organ of an individual. A computational backend environment, forexample, comprises a computing device 2006, a processor 2008, graphicaluser interface 2012 (GUI), and a display 2010. Anatomical data isreceived from an external source 2002, 2004, spanning a plurality offile formats, where the input parameters are combined to visualize andoutput current density and/or current flow activity having ampere-basedunits displayed in the spatial context of the heart or other organanatomy using display 2010.

Devices, systems, media, and methods described herein are useful in theevaluation of current density and/or current flow of an organ in orderto produce a two or three dimensional representation of the same, forvarious animal and human organs using magnetic field analysis. The twoor three dimensional representation may be used for the purpose ofdiagnosing abnormalities or guiding clinical treatment of the same.

The computational backend environment includes a visualizationapplication. A visualization application of the computational backendenvironment produces, for example, a visual two or three dimensional orfour dimensional (i.e., three dimensional plus time) or other renderingof an electroanatomical model of the organ in combination with a userinterface 2012 through which processing may occur. In some embodiments,the interface 2012 is configured to provide a user with the ability tomanipulate a displayed two or three dimensional image of an organ aswell as a two or three dimensional map overlay as described herein. Insome embodiment, the interface 2012 is configured to provide a user tofurther segment or section the organ so that slices of the organ may beviewed and manipulated on the screen. For example, user interface 2012is configured to allow a user to take slices of variable thicknessthrough a heart to view an endocardial layer. Such embodiments areconfigured for a user to, for example, view a current density or currentvector map overlaying the endocardium of the heart at differentselectable depths.

In the backend, three dimensional data can be rendered and manipulatedusing various methods. In this regard, the computational backendenvironment can be manipulated to quantify sensed data associated withan organ such as electrophysiological data in a way which allows fordiagnosis and/or output of treatment options based on the visualizationof distributed current vectors of the organ overlaid on a two or threedimensional geometry of the organ. For example, distributed currentvectors of a heart may be overlaid on a two or three dimensionalgeometry of the heart.

As shown, one or more organ electromagnetic sensors 2002 and 2004 areconfigured to be positioned external to the body of an animal or humanindividual and sense data associated with an organ of said individual.The sensed data may comprise magnetic field data associated with anorgan. For example, the heart of an individual conducts an electricalcurrent through the myocardial tissue of said heart during normalphysiologic function which generates an associated magnetic field thatis sensed by the one or more organ electromagnetic sensors 2002 and2004.

The one or more organ electromagnetic sensors 2002 and 2004 areconfigured to communicate with a computing device 2006. Suchcommunication may be through wireless or hardwired connections betweenthe organ electromagnetic sensors 2002 and 2004 and the computing device2006. The devices, systems, media, and methods described herein maycomprise an electromagnetic signal acquisition module or step. Anelectromagnetic signal acquisition module or step is configured toreceive a signal transmitted from one or more sensors.

The organ electromagnetic sensors 2002 and 2004 are networked tocooperate in sensing signals, wherein one or more organ electromagneticsensors 2002 and 2004 are both networked with each other as well asnetworked with a computing device 2006.

Non-limiting examples of sensed measurement types sensed by said organelectromagnetic sensor comprise a magnetic field, an electrical current,an oscillation/rotation/spinning frequency, a spatial frequency, or agradient. Measurement units comprise Ampere, Volt, Gauss, Hertz, orSeconds. A measurement magnitude may comprise a scalar, an amplitude, ora length. A measurement direction/orientation and/or magnitude comprisesa vector, and a measurement location comprises an x-y-z coordinate withrespect to a defined origin, or a combination thereof. In someembodiments, a plurality of sensed data associated with an organ.

Various organ electromagnetic sensor designs are possible. For example,a sensor may be configured to sense a snap-shot response, or a sequenceof snap-shop responses, or a continuous analog response over time. Insome embodiments, a plurality of sensors collectively acquires aplurality of responses. In additional embodiments, synthesis of aplurality of responses reconstructs activities of an organ. Furthermore,analyzing the responses associated with the organ or based on additionalknowledge/databases reveals electrical/molecular/mechanical/chemicalactivities in the organ. Non-limiting examples of sensors suitable foruse with the devices, systems, media, and methods described hereininclude electromagnetic sensors such as Superconducting QuantumInterference Devices (SQUIDs) and Atomic Magnetometers. A Magnetometeris configured to sense a Magnetocardiogram of a heart. A Magnetometermay be further configured to sense magnetic field data relating to otherorgans.

In some cases, an electromagnetic field comprises a purely magneticfield or a purely electrical field. In some embodiments, a sensedelectromagnetic field is oriented to a point or a plane of interestassociated with an organ. One or more electromagnetic fields associatedwith an organ may be sensed in order to locate a specific portion (e.g.,a point, a plane, a three dimensional region, etc.) of said organ.

While FIG. 2 exemplifies two organ electromagnetic sensors 2002 and 2004in communication with a computing device 2006, it should be understoodthat multiple configurations of sensors and computing devices aresuitable for use with the devices, systems, media, and methods describedherein. For example, one organ electromagnetic sensor may be configuredto communicate with one computing device. For example, one organelectromagnetic sensor may be configured to communicate with two or morecomputing devices. For example, one or more organ electromagneticsensors may be configured to communicate with one or more computingdevices. Numerous suitable computing technologies are suitable for useas a computing device 2006 including but not limited to a desktopcomputer, a laptop computer, a tablet computer, a smartphone, or asmartwatch. A computing device 2006 comprises a processor 2008 throughwhich, for example, magnetic field data sensed by one or more organelectromagnetic sensors is translated to current vector data and/orcurrent density data associated with specific anatomic locations of saidorgan. A computing 2006 either comprises or is coupled with a GUI 2012that allows a user to analyze, control, and interact with the datasensed by the organ electromagnetic sensors 2002 and 2004 and/or imagedata and or translated data. A computing device 2006 either comprises oris coupled with a display 2010 that is configured to display the currentdensity and/or current vector map of the organ being evaluated. Thedisplay and/or the GUI 2012 may be coupled directly with each other,directly with the computing device 2010, or one or both may be remotelylocated.

The system further comprises a connection to either an imaging device oran imaging database 2014. Non-limiting examples of imaging devices 2014suitable for use with the systems, devices, media, and methods describedherein include a CT scanner, an MRI, an ultrasound, a fluoroscope, anuclear scanner, an X-ray, and any other device configured to generatean anatomical image or representation of an organ. An imaging database2014 comprises a database of images from any one or more of the imagingdevices 2014. In some embodiments, an image or representation of anorgan of a subject or a demographically matched image of an organ istransmitted from the imaging device or imaging database 2014 to thecomputing device 2006 of system 2000.

In an alternative embodiment, a representation of an organ beingevaluated is generated based on the data sensed from organ sensors 2002and 2004. Computing device 2006 is configured to combine current vectorand/or current density data translated by said processor 2008 from thereceived magnetic field data and combine the current vector and/orcurrent density data with an image or representation of an organ by, forexample, overlaying the current vector and/or current density data overthe received image or representation of an organ.

Alternatively computing device 2006 generates a visual representation ofan organ being evaluated by visually displaying current densities and/orcurrent vectors translated from said sensed magnetic field data in anarrangement that represents the anatomical configuration of the organbeing sensed. The generated overlay image or representative imagecomprises a map wherein one or more current vectors and/or currentdensity are represented by different icons positioned in an anatomicalposition which the icons are associated with. For example, in saidgenerated map, a current density of a left ventricle of a heart ispositioned in a location corresponding to the anatomic location of theleft ventricle in space. In this way, a user may look at a display mapand visually identify one or more current vectors and/or currentdensities associated with various anatomic locations of an organ. Saidgenerated map is configured to be displayed as either a two or threedimensional map on display 2010. A GUI 2012 is configured to provide auser the ability to manipulate the generated map by, for example, movingthe generated map to view different angles or locations. A GUI 2012 isconfigured to provide a user the ability to examine slices through anorgan so that, for example, the user may view one or more currentvectors and/or current densities associated with tissue within theorgan.

Described herein are systems comprising one or more electromagneticsensor devices and at least one processor configured to executeinstructions from a software application. Said systems are configured toobtain and provide electrical activity data as a function ofelectromagnetic activity in response to measurements (e.g.,electrical/magnetic data values) for an organ (for example a heart) asan output of said sensor and input of said processor, wherein saidsensed data associated with an organ includes a representative series ofrecordings defining distributed electromagnetic activity (such ascardiac electromagnetic data) in three dimensional vector space during aspecified time period and specified time period markers for theaforementioned recordings. Said system utilizes organ tissue anatomicaldata (for example, heart anatomical data), wherein said data includes aplurality of data files providing electronic three dimensional or othermappings of organ geometry (such as heart geometry) embodied onnon-volatile memory, and processes by computer processor the inputmagnetic activity data provided by a sensor and the input organ tissueanatomical data (e.g., the heart anatomical data). Processing includescalculating a plurality of distributed, spatially accurate electricalcurrent vectors (with units of amperes or other suitable units) in twoor three dimensional space and uniquely identifying and outputting themin reference to anatomical structures found within an organ anatomicgeometry. In some embodiments, an organ evaluation device, system,medium, or method also displays both electrical current vectors andanatomical tissue (e.g. heart or other organ) or other anatomic senseddata associated with an organ simultaneously through the process ofimage registration, wherein said registration involves functionaloverlay of three dimensional anatomical reconstruction withelectroanatomical data provided by computational processing.Non-limiting examples of computing devices suitable for use with thesystems, devices, media, and methods described herein includes asmartphone, a smartwatch, a laptop computer, a desktop computer, and atablet computer.

III. Organ Evaluation Process

Devices, systems, media, and methods described herein are configured togenerate organ evaluations (for example, heart evaluations) and enablemeasured activity of the current density and/or current flow of theorgan through transformation of sensed data associated with an organcomprising sensed electromagnetic field data generated by the organ. Forexample, the devices, systems, media, and methods described herein areconfigured to generate cardiac evaluations and enable measured activityof whole-heart current density and/or current flow throughtransformation of sensed electromagnetic field data generated by theheart and specifically by current passing through the myocardium of theheart.

The transformation of sensed data associated with an organ comprisingmagnetic field data associated with an organ comprises the solution ofan inverse problem, wherein the solution involves the utilization ofMaxwell's Laws of Electromagnetism to relate magnetic measurements,collected by electromagnetic sensors, and electrical currentmeasurements. Determining the current density and/or current flow and/orelectrical activity involves solving an implementation of an inverseproblem using Maxwell's Electromagnetic Equations with explicitattention to spatial location and known geometries of the organ, forexample, the heart. In doing so, vector calculus and systems of partialdifferential equations are utilized to uniquely define the organ (forexample, the heart) in a two or three dimensional context, while solvingfor current using magnetic field and these defined spatial parameters toproduce current vectors for the entire spatial representation of theorgan (for example, the heart). Utilizing the Biot-Savart Law, theinverse problem as defined by its systems of partial differentialequations are solved numerically via finite element methodologies whichallow input data to be related to electrical current behavior, aslimited by the structure and physically relevant constraints of theorgan's (for example, the heart's) electromechanics. In this way,algorithmic input and processing of data are used to generateinformation about current flow in the organ (for example, the heart).

One or more mathematical transforms and or projections are used totransform raw measurements sensed from an organ (e.g. a heart) relatingto sensed data associated with an organ. For example, electromagneticdata associated with an organ is measured in a frequency space, and aFourier transform is employed to infer corresponding responses in aspatial space or in a space of electrical currents. For instance, aRadon transform or a Penrose transform is used for synthesizingresponses in a three dimensional space. Via the aforementioned finiteelement methodologies, Fourier transforms and appropriate analogues areused to spatially transform the coordinates of the input source to thecalculated current source described above.

Measurement of an electromagnetic field or a plurality ofelectromagnetic fields associated with an organ allows measurement of aproperty of an entire organ or a portion of an organ. For example, ameasurement of an electromagnetic field or electromagnetic fieldsassociated with an organ allows measurement of a current density and/orcurrent flow associated with said organ or a segment of said organ. Nonlimiting examples of other measurements that may be measured bymeasuring the electromagnetic field associated with an organ include anenergy state associated with said organ, a polarization state associatedwith said organ, a polar orientation associated with said organ, anoscillation frequency associated with said organ, a rotation/spinningfrequency or speed associated with said organ, an electrical currentassociated with said organ, a an electrical voltage associated with saidorgan, a change in mass associated with said organ, a presence of orchange in a mechanical force associated with said organ, a presence ofor change chemical force associated with said organ, or any combinationthereof. Measurement of an electromagnetic field or a plurality ofelectromagnetic fields associated with an organ also allows measurementof temporal organ physiology (e.g., a myocardial movement during acardiac cycle, a brain functioning over time, etc.).

Device, system, media, or method described herein comprise a dataintegration module, or use of the same. In some embodiments, sensed dataassociated with an organ is integrated with other information, e.g.,organ geometry, organ physiology. In some embodiments, measurements ofan individual's cardiac (or other) electrical activity responding tomagnetic field excitation are collected over time through a network ofelectromagnetic sensors, and anatomical heart (or other) geometry datais imported from one of a plurality of file formats relating to apatient. In some embodiments, processed measurements of electricalactivity that create distributed current vectors and/or currentdensities in units of amperes or other suitable units, are overlaid onthe imported heart (or other organ) geometry in a representative mannerwith real time context to demonstrate whole-heart or whole-organ vectormap and/or current density.

Integrating sensed data associated with an organ (e.g., electricalcurrents) with other types of data may comprise a synchronizationprocess. For example, overlying temporal sensed data associated with anorgan on a template of a myocardial geometry includes synchronizing acardiac cycle. Thus one or more images are time synched with a cardiaccycle as well as with the corresponding sensed magnetic field data. Insome embodiments, the time synched images are displayed in a movie orstreaming format such that a time synched current density or currentvector map is overlayed on the one or more streaming images so that themap(s) are viewed over time through the cardiac cycle. Similar timesynching through integration of data is also applied to other organswherein a change in the current density or current vector map isdisplayed over time.

In some embodiments, an organ evaluation device, system, medium, ormethod receives sensed data associated with an organ (e.g., magneticdata) from an individual which data are integrated with a pre-renderedand demographically compatible two or three dimensional organ imagemodel within a computational backend environment where the inputparameters are combined to visualize two or three dimensionalelectroanatomical images, without the need for individual-specificimages. The computational backend environment then evaluates said imagesfor potentially ectopic electrophysiological activity, particularly asit relates to triaging chest pain in the emergency room. In this regard,the computational backend environment can evaluate magnetic field dataover a cardiac cycle in a way which allows for an accurate two or threedimensional visualization and output of an urgency index depicting thedegree of urgency or lack thereof, for said patient. For example, anindividual experiencing an acute onset of arrhythmia can be evaluatedimmediately during the period of arrhythmia even if no image of theindividual's organ is available by using an image of an organ of ademographically matched individual that is, for example, matched to theindividual being evaluated by factors such as demographic, biometric, ormedical history related factors.

An organ evaluation device, system, medium, or method is configured tosense data associated with an organ (e.g., electrical currents,electrical current vectors, etc.) and electronically imported anatomicalcardiac tissue image data, which provides for joint registration ofelectrical and anatomical data based on landmark and structureidentification. Registration refers to data-skin overlay of a two orthree dimensional image such that quantitative data is displayedqualitatively with a plurality of color gradients bound to certainquantitative scales in two or three dimensional space, with particularrelation to said structures and landmarks. In some embodiments, an organevaluation device, system, medium, or method includes predeterminedembodied anatomical cardiac (or other organ) tissue that is selectionbased on a plurality of indicated demographic and lifestyle factors;wherein the demographics and lifestyle factors may include but are notlimited to factors of health status, age, gender, a priori illness,inflammation, scar tissue, diet, smoking, and substance use. In someembodiments, the process of selection of the data involves externalselection as a function of the preceding demographic factors.

An organ evaluation device, system, medium, or method may be furtherconfigured to analyze one or more electromagnetic fields associated withan organ to provide a comprehensive assessment of the functionalelectrophysiology of said anatomical organ. The sensed electromagneticfield associated with said organ may be further associated with one ormore other types of physiological measurements (e.g., EEG, ECG) toprovide a comprehensive assessment of the functional electrophysiologyof an anatomical organ. For example, an organ evaluating system providesa comprehensive assessment of functional cardiac electrophysiology, andsaid assessment further comprises one or more biometric measurements.Non-limiting examples of biometric data includes a heart rate, a heartvariability, a blood pressure, a temperature, and an electrocardiogram.Similarly, an evaluation of any organ may further comprise one or moresensed biometric measurements.

A computer implemented method comprises an evaluation through detecting,localizing and quantifying arrhythmogenic substrates in the heart.

A device, system, medium, and or method for visualizing two or threedimensional electroanatomical images may be configured to comprisecardiac imaging data and functional magnetocardiogram data associatedwith an cardiac of an individual. An organ evaluating system isconfigured to provide a two or three dimensional map of the electricalcurrent that travels through an organ. The electrical current thattravels through an organ is mapped into a two or three dimensionalrepresentation of the organ from which the current data was sensed.Alternatively or additionally, the electrical current that travelsthrough an organ is mapped into a three dimensional representation ofthe organ from which the electrical current data was sensed. Forexample, in some embodiments, an cardiac evaluating device, system,medium, or method identifies an abnormal current pattern in an area of aheart of an individual with an arrhythmia. In additional embodiments,the abnormal current along with the current pattern of the entire heartis mapped in either a two or three dimensional representation of theheart of the individual so that the current abnormality is localized toa specific area of the heart. In further embodiments, the arrhythmiatype may be, for example, identified as a localized arrhythmia typeamenable to treatment with catheter ablation, and the accuratelocalization of the area of abnormal current flow allows for successfuland accurate ablation.

An organ evaluation device, system, medium, or method generates a visualrepresentation of an evaluation of an organ, which is used by aphysician or health care professional to diagnose electrophysiologicaldisorders or lack thereof in the heart, or organ of interest, byidentifying the existence or lack thereof, of patterns of currentabnormality and regions of inactivity or arrhythmia, and enabling a userto recognize the existence or lack thereof relating to patterns ofcurrent abnormality and locate regions of inactivity or arrhythmia.

An organ evaluation device, system, medium, or method may be configuredto output distributed current vectors and two and three dimensionalmapping of heart geometry or other organ geometry for an individual. Insome embodiments, an organ evaluation device provides a softwareapplication and a user interface. An organ evaluation device, system,medium, or method may be configured to import and utilize twodimensional or three dimensional data embodied in a plurality of varioussuitable file types relating to anatomical geometry, and provides asystem for the importation and utilization of sensed data associatedwith an organ (e.g., magnetic field data) provided by one or moresensors, such as, for example, one or more electromagnetic sensors. Insome embodiments, an organ evaluation device, system, medium, or methodfurther provides an electronic visual display software application, thedisplay showing both magnetic amplitude waveforms and distributionvectors, and interpreting by said application components of threedimensional anatomical distributed current models through a spatiallyoriented user interface, in which a user is capable of manipulating therendered object through aforementioned GUI to alter field of view andenlarge or shrink the object. In some embodiments, a user interfaceallows for manual manipulation through said user interface of spatialobservation for the individual, and wherein said manipulation includesalteration of said image through said computational backend andalteration includes manipulation of nonstructural qualitative factorsincluding but not limited to color, position, and opacity. In someembodiments, accumulated electrical vector data identifies uniquespatial landmarks and structures such as but not limited to the septum,valves, or conducting nodes in the heart. The specific landmarks may bedifferent in different embodiments, depending on the organ of interest.

An organ evaluation device, system, medium, or method for quantifyingand displaying distributed cardiac current vector activity for anindividual, configures electrical activity data provided by a processor,wherein the step of configuring includes determining the file format ofthe data provided.

An organ evaluation device, system, medium, or method for quantifyingand displaying cardiac current density activity for an individualcalculates distributed cardiac current vector activity in dynamic,time-based parameters as distributed current density changes in time, inboth magnitude and spatial direction during the course of both regularand irregular heart rhythm.

An organ evaluation device, system, medium, or method configured forquantifying and displaying distributed cardiac current density activityfor an individual additionally provides an activity database of currentdensity output having baseline activity recordings. In some embodiments,an organ evaluation device, system, medium, or method further interpretssensed data associated with an organ comprising sensed magnetic fielddata and externally selected anatomical data, wherein interpretationcomprises comparing provided externally selected anatomical data withdatabase baseline activity recordings, and evaluating by the comparisonof activity as a function of risk assessment, where greater deviationsfrom accepted baseline activity are indicated as higher risk factors andare directly related.

An organ evaluation device, system, medium, or method may be configuredto sense a current density of an organ and/or a current flow through anorgan. The current flow may comprise an electrical current flow. Anelectrical current density and/or current flow may be represented by oneor more current vectors representing the direction and magnitude ofcurrent flow. One or more current vectors may be mapped in relation tothe anatomical area of an organ wherein the one or more current vectorsare measured. For example, a current vector sensed within the ventricleof a heart of an individual is mapped in that anatomical location withina representation of the heart of the individual.

An organ evaluation device, system, medium, or method may be configuredto sense an electrical field around an organ of an individual. Anelectrical field around an organ is measured with one or more sensors.In some embodiments, electrical field data sensed from an organ of anindividual is translated to a current flow represented by currentvectors, which represent flow of electrical current through the tissueof said organ.

An organ evaluation device, system, medium, or method may be configuredto generate an anatomical image of the organ evaluated. Alternatively oradditionally, the anatomical image comprises an overlay of a currentvector map of the organ over either a two dimensional or threedimensional image of the organ. The two or three dimensional image ofthe organ may, for example, comprise a CT scan of the organ. The two orthree dimensional image of the organ may, for example, comprise an MRIof the organ. The two or three dimensional image of the organ may, forexample, comprise a fluoroscopic or X-ray image of the organ.

In some embodiments, an organ evaluation device, system, medium, ormethod evaluates data from an individual in light of or in combinationwith patient demographic data. In some embodiments, organ related datais integrated in a computational backend environment with inbuiltanatomical data where the input measurements may be combined with theselected anatomical parameters to visualize and output current densityactivity having, for example, ampere or other units displayed in thespatial context of the anatomy of an organ, such as, for example, heartanatomy. In some embodiments, the computational backend environmentincludes a visualization application, which in certain embodimentsfurther comprises a user interface through which processing may occur.In some embodiments, in the backend, three dimensional data is generatedand can be rendered and manipulated. In additional embodiments, thecomputational backend environment quantifies electrophysiological datain a way which allows for an accurate diagnosis and output of treatmentoptions for medical patients based on the display and visualization ofdistributed current vectors overlay on three dimensional cardiacgeometry. In some embodiments, demographic data of an individual or ofone or more other individuals are combined with the magnetic data togenerate an evaluation of the organ of said individual. Demographic datamay comprise, for example, age, gender, height, and weight data.Demographic data may comprise, for example, anatomical data such as forexample the size, shape, and weight of an organ. In some embodiments,the magnetic field data associated with an organ of an individual iscombined with, for example, the organ size, shape, and weight of anotherindividual who is age, gender, and weight matched to said individualbeing evaluated.

Magnetic field measurements are processed to electrical activity data tocreate distributed current vectors in units of amperes or other units.In some embodiments, one or more current vectors are overlaid on aselected organ geometry in a representative manner with real timecontext to demonstrate whole-organ current density. Various techniquesmay be used to create the overlay. The measurements of one or moredistributed current vectors are calculated and represented by treatmentof each of a plurality of spatial points as individual contributors tocardiac current and electrical activity. In some embodiments, theevaluation of a determined distributed current vector activity isperformed through a two or three dimensional rendering of an organ of anindividual being evaluated. In some embodiments, a three dimensionalrendering of an organ of an individual comprises a CT scan or MRI imageof the organ. In some embodiments a three dimensional image of an organof an individual is constructed using one or more two dimensional imagesof said organ, such as, for example, images obtained through fluoroscopyor X-ray. In some embodiments, a two or three dimensional image of ademographically representative patient is used using the aforementionedsoftware application. In some embodiment, a three dimensional image isgenerated using one or more two dimensional images.

A device, system, medium, and method for organ evaluation enablesvisualization of inbuilt organ anatomy, such as, for example, cardiacanatomy with real time context by utilizing a software interface andcomputer backend to generate an accurate, three dimensionalrepresentation of the electrical activity of the entirety of, or atleast part of, a heart or other organ. Whole-heart current density ismeasured and visually represented with a software application and inreal time context through joint registration of qualitativelyrepresented current data and either specific or non-specific,representative anatomical data of an individual. As described, cardiactissue anatomical data is embodied as predetermined anatomical imagedata that includes unique identifiers of corresponding structures andlandmarks, and may be presented in various forms.

Described herein is a computer implemented method for evaluation throughdetecting, localizing and quantifying localized points of interest orabnormality, in an anatomical organ. The method comprises the steps ofproviding an electromagnetic sensor device having at least one processorconfigured to execute instructions from a software application;providing a computer backend having at least one processor configured toexecute instructions from a software application having a plurality ofinputs and outputs; providing electrical activity data as function ofelectromagnetic activity in magnetic data values for the anatomicalorgan tissue as an output of said sensor and input of said backend,wherein said data includes a representative series of recordingsdefining distributed anatomical organ tissue electromagnetic activity inthree dimensional vector space during a specified time period andspecified time period markers for the aforementioned recordings;utilizing anatomical data for anatomical organ tissue, wherein saidanatomical organ tissue data includes a plurality of data filesproviding electronic three dimensional mappings of heart geometryembodied on non-volatile memory. The method further includes processingby said computer processor the input magnetic activity data provided bysaid sensor and input anatomical organ tissue data, wherein the step ofprocessing includes calculating a plurality of distributed, spatiallyaccurate electrical current vectors (with units of amperes) in threedimensional space and uniquely identifying and outputting them inreference to anatomical structures found within said anatomical organgeometry files; and displaying both electrical current vectors andanatomical data simultaneously through the process of imageregistration, wherein said registration involves functional overlay ofthree dimensional anatomical reconstruction with electroanatomical dataprovided by computational processing.

An organ evaluation device, system, medium, or method for detecting,localizing and quantifying arrhythmogenic substrates in a heart or otherorgan for an individual is provided. The system comprises: anelectromagnetic sensor network including an electromagnetic sensor andcomputer backend having at least one processor and memory, wherein saidprocessor is configured to execute instructions from a softwareapplication to cause the electronic device to process electricalactivity data for the heart or other organ tissue, wherein said dataincludes a representative series of recordings defining distributedelectrical activity in three dimensional vector space during a specifiedtime period and specified time period markers for the aforementionedrecordings, and wherein the step of processing includes calculating aplurality of distributed, spatially accurate vectors with units ofelectrical current in three dimensional space and uniquely identifyingthem in reference to anatomical cardiac data, wherein said anatomicalcardiac data includes a plurality of data files providing electronicthree dimensional mappings of heart geometry embedded on non-volatilememory. Current vector activity is visualized via qualitativerepresentations of numerical values, by means of scales such as colorpatterns overlaying the rendered anatomical image, also known aselectroanatomical registration, to demonstrate current density and/orflow. In this embodiment, the registered image may be manipulatedvarious ways within software to change aspects of the image, such asspatial view, color, and opacity or other chosen qualities. Please referto FIGS. 3 through 11 for examples of such representations according tovarious embodiments of the invention.

IV. Exemplary Cardiac Evaluation Displays

FIG. 3 exemplifies an embodiment of a cardiac evaluation system displayshowing a current density and current vector map of a heart of anindividual comprising of combined functional current data as observedand manipulated in the software application. Note here that thedistributed current vectors are defined in the context of theirmagnitudes as points in three dimensional space, wherein the value ofthe current density in Ampere-based units is displayed using a dynamiccolor scheme, but other techniques for representing different amperagelevels may be used in other embodiments. More specifically, FIG. 3exemplifies a software screenshot representation 3000 of combinedanatomical and functional imaging showing distributed current vectors asarrows on a three dimensional cardiac surface. As shown, the size of anarrow representing a particular current vector is based on the magnitudeof current measured by the vector (i.e. a larger arrow represents alarger magnitude of measured current and a smaller arrow represents asmaller magnitude of measured current). The software viewer 3000 allowsfor localization of arrhythmogenic substrates within either a specificor nonspecific cardiac anatomy. A specific cardiac anatomy comprises ananatomy of an heart of an individual as shown in an image or otherrepresentation of the heart of the individual being evaluated. Anon-specific cardiac anatomy is an image or other representation of aheart that closely resembles that of the individual being evaluated andis capable of guiding treatment for a physician. Arrhythmogenicsubstrates may be described as localized points of interest or ofabnormality of the heart, but other substrates that are representativeof localized points of interest or of abnormality of other organs areused in other embodiments. In addition, while processing, the softwareimplemented method and system may also perform a step of configuringelectronic files containing data of current density activity in two orthree dimensional space, if such files are in a non-readable fileformat, to enable the underlying measurements to be extracted andpopulated into readable file formats. Current density is represented bydifferent colors according to key 3008 which shows a scale of colorscorresponding to Amperes of current per unit area. For example, currentdensity 3002 which appears as blue to light blue in color represents anapproximate Ampere density value between 1.09 and 1.88 according to key3008. As shown, current density 3002 is over an anatomical portion ofthe heart in the shown map corresponding approximately to the leftatrium. Similarly, as shown, current densities of multiple colors areshown over region 3004 which according to key 3008 correspond to anAmpere density values between 2.66 and 4.24. As shown, region 3004corresponds to the left ventricle. Thus, the current density seen in3004 represents an increased current density in the left ventriclerelative to the left atrium and thus typically, in the normalindividual, represents the heart in systole, wherein the left ventriclecontracts and the left atrium is relatively relaxed. The vectors shownover region 3006 are the largest in magnitude in the map and generallyshow that the largest magnitude of current, which are directed in adirection from the apex 3010 of the left ventricle upwards along theleft ventricle and laterally towards the right side of the heart. Region3004 shows the current density over the right side of the heart.

FIG. 4 exemplifies a screenshot 4000 of an embodiment of a cardiacevaluation system display showing a current density map of a heart of anindividual including an extraction tool 4002. An extraction tool 4002 ispart of a GUI that is configured to allow a user to obtain desired viewsof a current density map of an organ such as a heart. For example, asshown in FIG. 4, an extraction tool 4002 provides a user with a view ofa section or slice of a myocardium of a heart, thus showing an electriccurrent map through a slice of a heart revealing current density of thesub-surface myocardium.

FIG. 5 exemplifies a screenshot 5000 of an embodiment of a cardiacevaluation system display showing a current density map comprising anendocardial analysis. As shown, a cardiac current map of an endocardialportion of a heart of a subject shows a current density map of thesub-surface myocardial tissue of said subject. In this way, the wholeheart may be evaluated and not just the superficial myocardial tissue.

FIG. 6 exemplifies a screenshot of an embodiment of a cardiac evaluationsystem display showing a wireframe perspective of a current density mapof a heart 6000. A wireframe perspective comprises a higher resolutionperspective wherein a current density is sensed and displayed over asmaller region of surface of the heart.

FIG. 7 exemplifies a screenshot of an embodiment of a cardiac evaluationsystem display showing a current density map of an isolated leftventricle 7000. As shown, a portion of the cardiac anatomy may bedisplayed in isolation so that user may evaluate, for example, a cardiaccurrent density map of a left ventricle of a heart.

FIG. 8 exemplifies a screenshot of an embodiment of a cardiac evaluationsystem display showing a current density map of an isolated rightventricle 8000. As shown, a portion of the cardiac anatomy may bedisplayed in isolation so that user may evaluate, for example, a cardiaccurrent density map of a right ventricle of a heart.

FIG. 9 exemplifies a screenshot of an embodiment of a cardiac evaluationsystem display showing a current map of a heart during a QRS complex ofan ECG 9000. As shown, a cardiac current density map may be combinedwith ECG data to generate an evaluation of a heart of an individual,wherein a cardiac current density map is generated while the individualhas an ECG measured.

FIG. 10 exemplifies a screenshot of an embodiment of a cardiacevaluation system display showing an embodiment of a dynamic currentdensity of an individual in atrial fibrillation 10000. Analysis andrecognition of abnormal current density maps such as the one shown areachieved, for example, by comparison to normal current density maps andother abnormal current density maps with known pathology. Analysis andrecognition of abnormal current density is further aided, for example,by incorporating patient biometric data such as for example heart rate,blood pressure, temperature, activity level, and heart rate variability.For example, elevated heart rate and increased heart rate variability ina patient with an abnormal current density map supports a diagnosis ofarrhythmia in said patient. The devices, systems, media, and methodsdescribed herein are configured to not only identify the presence of anabnormal rhythm, but are also configured to localize the abnormality toa specific area of the cardiac anatomy. For example, area 10002 of theshown current density map is an area of abnormal current densityindicating abnormal current conduction in this area of the myocardium ofthe atria, which is a finding consistent with atrial fibrillation. Thedevices, systems, media, and methods described herein are similarlyconfigured to identify and localize abnormal areas of myocardium inother arrhythmia types such that accurate diagnosis occurs, and ifablation is indicated, accurate ablation is facilitated by thelocalization of the abnormality to a specific area or areas of abnormalmyocardium.

VI. Computing Systems

FIG. 11 exemplifies a computer system 11001 that is programmed orotherwise configured to noninvasively evaluate an organ. The computersystem 11001 can regulate various aspects of the evaluation device,system, media, or method of the present disclosure, such as, forexample, controlling magnetic field emission, acquiring sensed dataassociated with an organ, analyzing the electrical current, mapping thecardiac activities on the myocardium, and etc. The computer system 11001can be an electronic device of a user, or a computer system that isremotely located with respect to the electronic device. The electronicdevice can be a mobile electronic device.

The computer system 11001 includes a central processing unit (CPU, also“processor” and “computer processor” herein) 11005, which can be asingle core or multi core processor, or a plurality of processors forparallel processing. The computer system 11001 also includes memory ormemory location 11010 (e.g., random-access memory, read-only memory,flash memory), electronic storage unit 11015 (e.g., hard disk),communication interface 11002 (e.g., network adapter) for communicatingwith one or more other systems, and peripheral devices 11025, such ascache, other memory, data storage and/or electronic display adapters.The memory 11010, storage unit 11015, interface 11002 and peripheraldevices 11025 are in communication with the CPU 11005 through acommunication bus (solid lines), such as a motherboard. The storage unit11015 can be a data storage unit (or data repository) for storing data.The computer system 11001 can be operatively coupled to a computernetwork (“network”) 11003 with the aid of the communication interface11002. The network 11003 can be the Internet, an internet and/orextranet, or an intranet and/or extranet that is in communication withthe Internet. The network 11003 in some cases is a telecommunicationand/or data network. The network 11003 can include one or more computerservers, which can enable distributed computing, such as cloudcomputing. The network 11003, in some cases with the aid of the computersystem 11001, can implement a peer-to-peer network, which may enabledevices coupled to the computer system 11001 to behave as a client or aserver.

The CPU 11005 can execute a sequence of machine-readable instructions,which can be embodied in a program or software. The instructions may bestored in a memory location, such as the memory 11010. The instructionscan be directed to the CPU 11005, which can subsequently program orotherwise configure the CPU 11005 to implement methods of the presentdisclosure. Examples of operations performed by the CPU 11005 caninclude fetch, decode, execute, and writeback.

The CPU 11005 can be part of a circuit, such as an integrated circuit.One or more other components of the system 11001 can be included in thecircuit. In some cases, the circuit is an application specificintegrated circuit (ASIC).

The storage unit 11015 can store files, such as drivers, libraries andsaved programs. The storage unit 11015 can store user data, e.g., userpreferences and user programs. The computer system 11001 in some casescan include one or more additional data storage units that are externalto the computer system 11001, such as located on a remote server that isin communication with the computer system 11001 through an intranet orthe Internet.

The computer system 11001 can communicate with one or more remotecomputer systems through the network 11003. For instance, the computersystem 11001 can communicate with a remote computer system of a user(e.g., mobile device, server, etc.). Examples of remote computer systemsinclude personal computers (e.g., portable PC), slate or tablet PC's(e.g., APPLE® iPad, SAMSUNG® Galaxy Tab), telephones, Smart phones(e.g., APPLE® iPhone, Android-enabled device, BLACKBERRY®), or personaldigital assistants. The user can access the computer system 11001 viathe network 11003.

Methods as described herein can be implemented by way of machine (e.g.,computer processor) executable code stored on an electronic storagelocation of the computer system 11001, such as, for example, on thememory 11010 or electronic storage unit 11015. The machine executable ormachine readable code can be provided in the form of software. Duringuse, the code can be executed by the processor 11005. In some cases, thecode can be retrieved from the storage unit 11015 and stored on thememory 11010 for ready access by the processor 11005. In somesituations, the electronic storage unit 11015 can be precluded, andmachine-executable instructions are stored on memory 11010.

The code can be pre-compiled and configured for use with a machine havea processer adapted to execute the code, or can be compiled duringruntime. The code can be supplied in a programming language that can beselected to enable the code to execute in a pre-compiled or as-compiledfashion.

Aspects of the systems and methods provided herein, such as the computersystem 11001, can be embodied in programming. Various aspects of thetechnology may be thought of as “products” or “articles of manufacture”typically in the form of machine (or processor) executable code and/orassociated data that is carried on or embodied in a type of machinereadable medium. Machine-executable code can be stored on an electronicstorage unit, such memory (e.g., read-only memory, random-access memory,flash memory) or a hard disk. “Storage” type media can include any orall of the tangible memory of the computers, processors or the like, orassociated modules thereof, such as various semiconductor memories, tapedrives, disk drives and the like, which may provide non-transitorystorage at any time for the software programming. All or portions of thesoftware may at times be communicated through the Internet or variousother telecommunication networks. Such communications, for example, mayenable loading of the software from one computer or processor intoanother, for example, from a management server or host computer into thecomputer platform of an application server. Thus, another type of mediathat may bear the software elements includes optical, electrical andelectromagnetic waves, such as used across physical interfaces betweenlocal devices, through wired and optical landline networks and overvarious air-links. The physical elements that carry such waves, such aswired or wireless links, optical links or the like, also may beconsidered as media bearing the software. As used herein, unlessrestricted to non-transitory, tangible “storage” media, terms such ascomputer or machine “readable medium” refer to any medium thatparticipates in providing instructions to a processor for execution.

Hence, a machine readable medium, such as computer-executable code, maytake many forms, including but not limited to, a tangible storagemedium, a carrier wave medium or physical transmission medium.Non-volatile storage media include, for example, optical or magneticdisks, such as any of the storage devices in any computer(s) or thelike, such as may be used to implement the databases, etc. shown in thedrawings. Volatile storage media include dynamic memory, such as mainmemory of such a computer platform. Tangible transmission media includecoaxial cables; copper wire and fiber optics, including the wires thatcomprise a bus within a computer system. Carrier-wave transmission mediamay take the form of electric or electromagnetic signals, or acoustic orlight waves such as those generated during radio frequency (RF) andinfrared (IR) data communications. Common forms of computer-readablemedia therefore include for example: a floppy disk, a flexible disk,hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD orDVD-ROM, any other optical medium, punch cards paper tape, any otherphysical storage medium with patterns of holes, a RAM, a ROM, a PROM andEPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wavetransporting data or instructions, cables or links transporting such acarrier wave, or any other medium from which a computer may readprogramming code and/or data. Many of these forms of computer readablemedia may be involved in carrying one or more sequences of one or moreinstructions to a processor for execution

The computer system 11001 can include or be in communication with anelectronic display 11035 that comprises a user interface (UI) 11004 forproviding, for example, distributions of magnetic fields, distributionsof electrical currents, distributions of local myocardial activities,etc. Examples of UI's include, without limitation, a graphical userinterface (GUI) and web-based user interface.

Methods and systems of the present disclosure can be implemented by wayof one or more algorithms. An algorithm can be implemented by way ofsoftware upon execution by the central processing unit 11005. Thealgorithm can, for example, image acquisition, image mapping, imageregistration, three dimensional organ reconstruction.

While preferred embodiments of the present subject matter have beenshown and described herein, it will be obvious to those skilled in theart that such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the present subject matter. It shouldbe understood that various alternatives to the embodiments of thesubject matter described herein may be employed in practicing thesubject matter described herein. It is intended that the followingclaims define the scope of the invention and that methods and structureswithin the scope of these claims and their equivalents be coveredthereby.

What is claimed is:
 1. A method of treating an individual with a cardiacarrhythmia, the method comprising: (a)measuring at least one magneticfield data associated with a heart of the individual; (b) translatingthe at least one magnetic field data to at least one current densityvalue of the heart of the individual; (c) graphically combining the atleast one current density value with a radiographic image of a heart togenerate a current density map of the heart of the individual, whereinthe current density map visually displays the at least one currentdensity value in an arrangement that represents an anatomically correctconfiguration of a heart; (d) identifying a region of the currentdensity map associated with the cardiac arrhythmia; and (e) ablating theheart at a location corresponding to the region.
 2. The method of claim1, wherein the current density map is non-invasively generated.
 3. Themethod of claim 1, wherein graphically combining the at least onecurrent density value with the radiographic image of the heart comprisesoverlaying the at least one current density value onto the radiographicimage of the heart.
 4. The method of claim 3, wherein the at least onecurrent density value is represented by an icon positioned at a spatiallocation of the current density map corresponding to an associatedanatomical position of the heart of the individual.
 5. The method ofclaim 1, wherein the cardiac arrhythmia comprises atrial fibrillation.6. The method of claim 1, wherein the current density map comprises athree-dimensional image.
 7. The method of claim 1, wherein the currentdensity map comprises a plurality of distributed, spatially accurateelectrical current values having dynamic, real-time parameters.
 8. Themethod of claim 1, wherein the radiographic image comprises atwo-dimensional X-ray image.
 9. The method of claim 1, wherein theradiographic image comprises a computed tomography (CT) scan.
 10. Themethod of claim 1, wherein the radiographic image comprises athree-dimensional image.
 11. The method of claim 10, wherein thethree-dimensional image is generated from two or more two-dimensionalX-ray images.
 12. The method of claim 1, further comprising receivingdemographic data associated with the individual.
 13. The method of claim12, wherein the demographic data comprises one or more of age, race,gender, and medical history of the individual.
 14. The method of claim13, further comprising using the received demographic data associatedwith the individual to identify an image of a heart of a differentindividual, wherein the demographic data associated with the individualand demographic data associated with the different individual areessentially identical in the one or more of the age, the race, thegender, and the medical history.
 15. The method of claim 14, wherein theradiographic image comprises the image of the heart of the differentindividual.
 16. The method of claim 1, further comprising receivingbiometric data associated with the individual, and identifying theregion of the current density map associated with the cardiac arrhythmiabased at least in part on the biometric data.
 17. The method of claim16, wherein the biometric data comprises one or more of a heart rate, aheart rate variability, a blood pressure, a temperature, an activitylevel, and an electrocardiogram of the individual.
 18. The method ofclaim 1, further comprising receiving physiological data associated withthe individual, and identifying the region of the current density mapassociated with the cardiac arrhythmia based at least in part on thephysiological data.
 19. The method of claim 18, wherein thephysiological data comprises one or more of electroencephalogram (EEG)data and electrocardiogram (ECG) data.
 20. The method of claim 1,further comprising measuring the at least one magnetic field dataassociated with the heart of the individual using at least oneelectromagnetic sensor configured to sense a magnetic field associatedwith a heart of an individual.
 21. The method of claim 20, wherein theat least one electromagnetic sensor comprises one or more of aSuperconducting Quantum Interference Device (SQUID) and an atomicmagnetometer.
 22. The method of claim 1, wherein translating the atleast one magnetic field data to the at least one current density valuecomprises applying one or more of a Fourier transform, a Radontransform, and a Penrose transform to the at least one magnetic fielddata.
 23. The method of claim 1, wherein the radiographic imagecomprises an image of the heart of the individual.